Module 9 2021

Combined ATMP

A combined ATMP must • Contain viable or non viable cells or tissue • Incorporate as an integral part of the prduct one or more medical device • The cellular part acts with a primary action to that of the device • Structural part must meet definition of device in 93/42/EEC or 90/385/EEC, and must retain its device function in the combination Basic EU regulatory Documents • Art 2(1)(d) of 1394/2007 Regulation Examples and applications • Autologous chondrocytes into a collagen membrane for joint cartilage lesion (MACI) • Autologous osteoprogenitor cells with bioresorbable scaffold for bone lesions • Limbial stem cells or endothelial cells with bioresorbable scaffold for ophthalmic applications

Novartis Pharma AG- Business use only- not for further distribution

31